In a general sense, the invention is directed to systems and methods for treating interior tissue regions of the body. More specifically, the invention is directed to systems and methods for treating dysfunctions of organs and tissue in the gastrointestinal tract.
Disorders of organs or tissue of the gastrointestinal tract can be caused by as neurological factors (such as abnormal nerve impulses) or by physical factors (such as excess tissue volume).
For example, intestinal motility (i.e., the contraction of intestinal muscles and the propulsion and movement of the lumenal contents) is controlled by nerves and hormones, as well as by electrical activity in the muscular wall of the intestine. There are several disorders that involve abnormal motility and result in abnormal and uncomfortable visceral sensations. These disorders can cause significant discomfort and distress in the absence of gross physical abnormality of the intestine.
For example, irritable bowel syndrome (IBS) is a common disorder of the intestines. IBS can lead to crampy pain, gassiness, bloating, and changes in bowel habits. Some people with IBS have constipation (difficult or infrequent bowel movements); others have diarrhea (frequent loose stools, often with an urgent need to move the bowels); and some people experience both symptoms intermittently. Sometimes the person with IBS has a crampy urge to move the bowels, but cannot do so. The cause of IBS is not known, and as yet there is no cure. IBS can be characterized as a functional disorder because there is no sign of disease when the intestine is examined. Often IBS is just a mild annoyance, but for some people it can be disabling.
Dyspepsia is another example. Dyspepsia is literally translated as xe2x80x9cbad digestionxe2x80x9d and is commonly known as indigestion. Motility-like dyspepsia causes persistent or recurring abdominal pain that is centered in the upper abdomen. People with motilityassociated dyspepsia also may experience bloating, nausea, burping and a feeling of fullness that occurs soon after eating. It is an extremely common symptom complex, affecting as much as one-fourth of the United States adult population.
There are other disorders affecting the gastrointestinal tract that are characterized by abnormal tissue conditions not associated with neural abnormalities.
The invention provides systems and methods that treat disorders of the gastrointestinal tract by applying one or more treatment agents to tissue at or near the region where abnormal neurological symptoms and/or abnormal tissue conditions exist. The treatment agent is selected to either disrupt abnormal nerve pathways, e.g., associated with dysmotility and/or discomfort, and/or to alleviate abnormal tissue conditions, e.g., to stiffen tissue in order to alleviate disease.
One aspect of the invention provides systems and methods that apply a selected treatment agent into contact with tissue at or in a region of the gastrointestinal tract where dysmotility and/or abnormal visceral sensations exist. The application of the treatment agent can provide relief from the pain and symptoms of nerve-related gastrointestinal disorders, such as irritable bowel syndrome or motility-like dyspepsia. Application of the treatment agent may also attenuate the dysmotility and alleviate the dysfunction itself. The systems and methods may be used as either a primary treatment modality, or may be applied before, during, or after some other primary intervention.
According to this aspect of the invention, the treatment agent includes at least one vanilloid compound. Presence of the vanilloid compound evokes a desired tissue response, which includes at least one of the following, e.g., the interruption of nerve impulses which leads to a reduction of the symptoms that are associated with abnormal nerve impulses, the diminution of pain impulses, the attenuation of the dysmotility, and/or the alleviation the disease state itself. The vanilloid treatment agent may be applied to surface tissue, or, alternatively, it may be injected into subsurface tissue. In one embodiment, the systems and methods can also apply energy to the tissue region to form at least one lesion in conjunction with application of the treatment agent.
Another aspect of the invention provides systems and methods that apply a selected treatment agent into contact with tissue at or in a region where an abnormal tissue condition exists in order to affect normal functionality.
According to this aspect of the invention, the treatment agent includes at least one sub-type of a cytokine. Presence of the cytokine evokes a desired tissue response, which can include, e.g., an initiation of a localized healing process including influx of white blood cells and fibroblasts, followed by deposition of collagen, and subsequent tissue compliance reduction and tightening. These effects will result in a reduction of tissue volume. The cytokine treatment agent may be applied to surface tissue, or, alternatively, it may be injected into subsurface tissue, including the submucosa.